Subcutaneous tocilizumab alone or with a csDMARD in rheumatoid arthritis patients: subanalysis of Italian data from a multicenter phase IIIb/IV trial

Laura Bazzichi, Francesca Nacci, Luigi Sinigaglia, Laura Bianchino, Roberto Caporali

Research output: Contribution to journalArticlepeer-review

Abstract

To assess, in a setting close to real life, the efficacy and safety of weekly subcutaneous tocilizumab (TCZ-SC) 162 mg, alone or with a conventional synthetic DMARD (csDMARD), in moderate-to-severe RA patients with inadequate response to DMARDs or anti-TNFα drugs. This national, multicenter, open-label, phase IIIb trial is part of an umbrella study (TOZURA). Patients were treated for 52 weeks followed by 8 weeks drug-free to evaluate immunogenicity. The primary end point was the Clinical Disease Activity Index (CDAI) change from baseline at weeks 2 and 24. Other efficacy parameters, including sleep quality, and the safety and immunogenicity were also assessed up to week 52. Of 288 patients enrolled in 43 Italian centers, 78.8% received TCZ-SC (86.8% females; mean age 54.7 ± 12.1 years; mean disease duration 7.8 ± 7.5 years; DMARD-IRs 94.7%). Of these, 78.0% completed the 52-week period and 52.0% received concomitant methotrexate. TCZ-SC yielded a significant reduction in median CDAI from baseline already at week 2, which progressed up to week 24 and remained stable thereafter (P 
Original languageEnglish
Pages (from-to)841-849
Number of pages9
JournalClinical Rheumatology
Volume38
Issue number3
DOIs
Publication statusPublished - Mar 2019

Keywords

  • Efficacy
  • Immunogenicity
  • Inadequate responders
  • Rheumatoid arthritis
  • Sleep quality
  • Subcutaneous tocilizumab
  • csDMARD
  • Adult
  • Aged
  • Antibodies, Monoclonal, Humanized/*administration & dosage/therapeutic use
  • Antirheumatic Agents/*therapeutic use
  • Arthritis, Rheumatoid/*drug therapy
  • Chloroquine/therapeutic use
  • Drug Therapy, Combination
  • Female
  • Humans
  • Hydroxychloroquine/therapeutic use
  • Injections, Subcutaneous
  • Leflunomide/therapeutic use
  • Male
  • Methotrexate/therapeutic use
  • Middle Aged
  • Sulfasalazine/therapeutic use
  • Treatment Outcome

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